5th February, 2022, 11am-12 noon

Speakers: Dr KK Kalra Director HCFI, Ex-CEO NABH; Dr Arati Verma Senior Vice President - Medical Quality, Max Healthcare; Ms Ira Gupta Advocate Privy Law Firm, Legal Advisor HCFI

Key points of HCFI Expert Round Table

• Litigations against doctors are increasing not only in India but also outside India. The objective of the standard of care is to provide the working physician with a practical and useful model to help guide daily practice as patient safety is a concern. Its especially relevant to emergency care.
• Standard of care becomes very important because of harm to the patient leading to litigations and mistrust. All standard of care concepts have come out of legal cases. There is no definition in legal system except guidelines and advisories issued by the Supreme Court from time to time.
• Every physician, including emergency physician should be aware of landmark cases that define standard of care. They should also be familiar with the various clinical practice guidelines so that one practices according to them or document the reason/s for deviation.
• Medical negligence requires four conditions to be met: duty, breach of duty, harm and causation. Breach of duty is synonymous with standard of care.
• US data shows that about 7-17 malpractice claims are filed per 100 physicians every year.
• The courts have frequently upheld that the standard of care is what a minimally competent physician in the same field would do in the same situation, with the same resources.
• Various definitions have been given from time to time.
• Initial definition was based on custom, that which is typically done is what is considered standard. In the 20^th century, to this definition was added anything that seems reasonable even if not typically done. The modern definition is that which a minimally competent physician in the same field would do under similar circumstances.
• A jury still needed to decide, whether this “custom” was reasonable and whether the deviation from this custom was so unreasonable as to cause harm.
• Standard of care does not mean perfection in practice.
• Some advisories have been given by the Courts of law. 
• Medical malpractice is a legal fault by a physician or surgeon. It arises from the failure of a physician to provide the quality of care required by law. When a physician undertakes to treat a patient, he takes on an obligation enforceable at law to use minimally sound medical judgment and render minimally competent care in the course of services he provides. A physician does not guarantee recovery… A competent physician is not liable per se for a mere error of judgment, mistaken diagnosis or the occurrence of an undesirable result.”
• “Medicine is an inexact science, and generally qualified physicians may differ as to what constitutes a preferable course of treatment. Such differences due to preference…do not amount to malpractice.”

• The law only requires minimal competence. The care does not even have to be average which makes sense; otherwise, 50% of all medical care would be malpractice by definition
• When one side uses a clinical practice guideline in a court case, it is up to the opposing side to ensure that the jury is given adequate explanation as to why this may or may not actually represent the standard of care. Guidelines should be flexible and include multiple sources of scientific merit and should not depend on only a small panel. If clear evidence is lacking, this should be openly acknowledged in the formation of the guideline.
• To understand the scope of negligence, it is important to understand the scope of duty imposed on a doctor. A doctor has a duty of care in deciding whether to undertake the case or not, duty in deciding what treatment to give, duty of care in administering the treatment and duty not to undertake any procedure beyond his or her control.
• Standard of care is an essential concept in determining whether a person was negligent and potentially liable for a tort. If a person breaches the standard that applies to them and their action causes harm to another person, they will be liable for negligence (US Legal Information Institute).
• The standard of care is the degree of care, skill or diligence with a reasonable and prudent man is required to use in particular situation in order to avoid the imputation of negligence.
• The standard of care required is a matter of law and does not vary according to the individual although it does vary according to the circumstances.
• There are several important landmark judgments that talk of guidelines, but courts are not legislative. 
• Doctors are mostly ignorant of the legal aspects of practice of medicine. There has been a corresponding increase in compensation awarded in medical negligence cases. Compensations amounting to more than one crore have been awarded by the Supreme Court of India and National Consumer Disputes Redressal Commission (NCDRC) in Nizam’s Institute of Medical Sciences vs Prasanth S Dhananka and Others on 14 May, 2009; Dr. (Mrs.) Indu Sharma vs Indraprastha Apollo Hospital on 22 April, 2015; V. Krishnakumar vs State Of Tamil Nadu & Others. on 1 July, 2015 and Dr Balram Prasad vs Dr Kunal Saha and Others.
• The constituents of medical negligence include a legal duty to exercise due care on the part of the medical professional, failure to inform the patient of the risks involved, the patient suffers damage as a consequence of the undisclosed risk. Breach of the said duty would give rise to an actionable claim of negligence.
• Actionable medical negligence is the neglect in exercising a reasonable degree of skill and knowledge to the patient, to whom he owes a duty of care, which has resulted in injury to such person.
• The law requires neither the very highest nor a very low degree of care and competence to adjudge whether the medical professional has been negligent in the treatment of the patient.
• Not all medical negligence cases are actionable medical negligence cases. There is a very fine line dividing the two.
• Law does not expect the highest standard nor dose it expect low standards. The standard of care expected is the standards of any reasonable medical practitioner. The circumstances in which a medical practitioner is placed always determines the standards expected from him. 
• The Hon’ble Supreme Court has come out with some guidelines in PB Desai vs State of Maharashtra.

• “(a) to continue to treat, except under certain circumstances when doctor can abandon his patient;
• (b) to take reasonable care of his patient;
• (c) to exhibit reasonable skill: The degree of skill a doctor undertakes is the average degree of skill possessed by his professional brethren of the same standing as himself. The best form of treatment may differ when different choices are available. There is an implied contract between the doctor and patient where the patient is told, in effect, “Medicine is not an exact science. I shall use my experience and best judgment and you take the risk that I may be wrong. I guarantee nothing.”-
• (d) Not to undertake any procedure beyond his control: This depends on his qualifications, special training and experience. The doctor must always ensure that he is reasonably skilled before undertaking any special procedure/treating a complicated case…”

• In Malay Kumar Ganguly vs Sukumar Mukherjee & Ors, “

“(i) No guarantee is given by any doctor or surgeon that the patient would be cured.

(ii) The doctor, however, must undertake a fair, reasonable and competent degree of skill, which may not be the highest skill.

(iii) Adoption of one of the modes of treatment, if there are many, and treating the patient with due care and caution would not constitute any negligence.

(iv) Failure to act in accordance with the standard, reasonable, competent medical means at the time would not constitute a negligence. However, a medical practitioner must exercise the reasonable degree of care and skill and knowledge which he possesses. Failure to use due skill in diagnosis with the result that wrong treatment is given would be negligence.

(v) In a complicated case, the court would be slow in contributing negligence on the part of the doctor, if he is performing his duties to be best of his ability. Bearing in mind the aforementioned principles, the individual liability of the doctors and hospital must be judged.”

• In Kusum Sharma & Others versus Batra Hospital & Medical Research Centre, the Supreme Court has laid down 11 principles to judge negligence.

1. Negligence is the breach of a duty exercised by omission to do something which a reasonable man, guided by those considerations which ordinarily regulate the conduct of human affairs, would do, or doing something which a prudent and reasonable man would not do.
2. Negligence is an essential ingredient of the offence. The negligence to be established by the prosecution must be culpable or gross and  not the negligence merely based upon an error of judgment.
3. The medical professional is expected to bring a reasonable degree of skill and knowledge and must exercise a reasonable degree of care. Neither the very highest nor a very low degree of care and competence judged in the light of the particular circumstances of each case is what the law requires.
4. A medical practitioner would be liable only where his conduct fell below that of the  standards      of a reasonably competent practitioner in his field.
5. In the realm of diagnosis and treatment there is scope for genuine difference of opinion and one professional doctor is clearly not negligent merely because his conclusion differs from that of the other professional doctor.
6. The medical professional is often called upon to adopt a procedure which involves higher element of risk, but which he honestly believes as providing greater chances of success for the patient rather than a procedure involving lesser risk but higher chances of failure. Just because a professional looking to the gravity of illness has taken higher element of risk to redeem the patient out of his/her suffering which did not yield the desired result may not amount to negligence.
7. Negligence cannot be attributed to a doctor so long as he performs his duties with reasonable skill and competence. Merely because the doctor chooses one course of action in preference to the other one available, he would not be liable if the course of action chosen by him was acceptable to the medical profession. 
8. It would not be conducive to the efficiency of the medical profession if no Doctor could administer medicine without a halter round his neck.
9. It is our bounden duty and obligation of the civil society to ensure that the medical professionals are not unnecessary harassed or humiliated so that they can perform their professional duties without fear and apprehension.
10. The medical practitioners at times also have to be saved from such a class of complainants who use criminal process as a tool for pressurizing the medical professionals/hospitals particularly private hospitals or clinics for extracting uncalled for compensation. Such malicious proceedings deserve to be discarded against the medical practitioners. 
11. The medical professionals are entitled to get protection so long as they perform their duties with reasonable skill and competence and in the interest of the patients. The interest and welfare of the  patients have to be paramount for the medical professionals.”

• In Nizam’s Institute of Medical Sciences vs Prasanth S Dhananka and Others, the Supreme Court ruled that the liability of the medical practitioner would be judged based on the standard of care on that day. “It is clear that a mere misjudgment or error in medical treatment by itself would not be decisive of negligence towards the patient and the knowledge of medical practice and procedure available at the time of the operation and not at the date of trial, is relevant. It is also evident that a doctor rendering treatment to a patient is expected to have reasonable competence in his field. (Bolams principle)”.
• Legal remedies available: Criminal complaint under IPC, complaint before the respective state medical councils, consumer complaint under the CPA, civil suit for recovery of compensation and alternate dispute redressal like mediation.
• Standard of care should be algorithm based and we should have digital standards, which are easy to follow.
• Exercise of standard of care at the healthcare facility or at the individual level can be ensured by improving system and processes by way of healthcare quality standards, accreditation standards (NABH, JCI), government (NHQUAS/IPHAS/CEA/MCI).
• In addition, there may be mandatory regulatory requirements or standard treatment guidelines under PMJAY. There are 625 standard treatment guidelines under this, which cover 1572 procedures. The idea behind having STG is to have standardisation in terms of treatment and promote effective and efficient treatment options. These guidelines have defined the eligibility of the practitioner to carry out a particular procedure.
• Accreditation is a very useful tool to bring about change in practice to standardize treatment in hospitals.
• There are 10 chapters in the accreditation standards of NABH which cover 84 standards with 651 objective elements. 30-40% of these objective elements refer to standardisation of the way we do our practice – supportive processes in clinical care as well as direct processes.
• In one chapter on care of patient, there is one standard which requires hospital to follow clinical care pathways as well as clinical care guidelines, which alludes to standard of care.
• The benefits of this are that clinical practice guidelines standardize clinical practice; using them reduces litigation risk and most importantly, reduces risk of deficiencies in any form of care to the patient. Clinical decision steps are easily memorized and these are very easily available to all to follow these pathways very easily when taking care of the patient. Care is provided in a timely fashion. Clinical practice guidelines also help in efficient use of appropriate resources.
• If a hospital starts adapting accreditation as a tool to improve their standard of care, everybody does it uniformly.
• The hospital has to audit and evaluate compliance to these guidelines, whether it is matching the best evidence or not.
• Accreditation promotes a non-punitive environment so that we are continuously learning and improving ourselves.
• It’s always best to get external audits done to ensure compliance with standards.
• The accreditation process should be simple, not cumbersome, but without compromising on the standards.
• All government hospitals must also get themselves accredited. NABH standards should be implemented in all medical colleges under NMC. But there is a resistance to accreditation.

Participants

Dr KK Kalra

Dr Ashok Gupta

Prof Bejon Misra

Dr Arun Jamkar

Dr Rai

Dr Arati Verma

Ms Ira Gupta

Mr Saurabh Aggarwal

Dr S Sharma